Transforming Lives Through Diabetes Research

S. Hrg.
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TRANSFORMING LIVES THROUGH DIABETES

RESEARCH
HEARING
BEFORE THE
COMMITTEE ON
HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
JUNE 22, 2011
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COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii
TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware
SCOTT P. BROWN, Massachusetts
MARK L. PRYOR, Arkansas
JOHN MCCAIN, Arizona
RON JOHNSON, Wisconsin
MARY L. LANDRIEU, Louisiana
ROB PORTMAN, Ohio
CLAIRE MCCASKILL, Missouri
JON TESTER, Montana
RAND PAUL, Kentucky
MARK BEGICH, Alaska
JERRY MORAN, Kansas
MICHAEL L. ALEXANDER, Staff Director
AARON M. FIROVED, Professional Staff Member
NICHOLAS A. ROSSI, Minority Staff Director
PRISCILLA H. HANLEY, Minority Professional Staff Member
TRINA DRIESSNACK TYRER, Chief Clerk
PATRICIA R. HOGAN, Publications Clerk
LAURA W. KILBRIDE, Hearing Clerk
(II)
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CONTENTS
Opening statements:
Senator Lieberman ...........................................................................................
Senator Collins .................................................................................................
Senator Akaka ..................................................................................................
Senator Brown ..................................................................................................
Senator Shaheen * ............................................................................................
Senator Lautenberg * .......................................................................................
Senator Pryor ....................................................................................................
Senator Begich ..................................................................................................
Prepared statements:
Senator Lieberman ...........................................................................................
Senator Collins .................................................................................................
Senator Akaka ..................................................................................................
Senator Brown ..................................................................................................
Senator Shaheen * ............................................................................................
* Guest Member
Page
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WITNESSES
WEDNESDAY, JUNE 22, 2011
Kevin Kline, Celebrity Advocate Co-Chairman, Juvenile Diabetes Research
Foundation ............................................................................................................
Griffin P. Rodgers, M.D., Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, U.S. Department
of Health and Human Services ...........................................................................
Charles Zimliki, Ph.D., Chairman, Artificial Pancreas Critical Path Initiative,
Center for Devices and Radiological Health, Food and Drug Administration,
U.S. Department of Health and Human Services .............................................
Caroline Jacobs, Delegate from Shapleigh, Maine, JDRF Childrens Congress .
Jack Schmittlein, Delegate from Avon, Connecticut, JDRF Childrens Congress ......................................................................................................................
Kerry Morgan, Delegate from Glen Allen, Virginia, JDRF Childrens Congress ......................................................................................................................
Jonathan Platt, Delegate from Tarzana, California, JDRF Childrens Congress ......................................................................................................................
ALPHABETICAL LIST
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WITNESSES
Jacobs, Caroline:
Testimony ..........................................................................................................
Prepared statement ..........................................................................................
Kline, Kevin:
Testimony ..........................................................................................................
Morgan, Kerry:
Testimony ..........................................................................................................
Platt, Jonathan:
Testimony ..........................................................................................................
Rodgers, Griffin P., M.D.:
Testimony ..........................................................................................................
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Schmittlein, Jack:
Testimony ..........................................................................................................
Zimliki, Charles, Ph.D.:
Testimony ..........................................................................................................
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APPENDIX
Charts submitted for the Record by Dr. Rodgers ..................................................
Letter and prepared statement from Mary Tyler Moore, JDRF International
Chairman ..............................................................................................................
Responses to post-hearing questions for the Record from:
Dr. Rodgers .......................................................................................................
Dr. Zimliki .........................................................................................................
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TRANSFORMING LIVES THROUGH DIABETES

RESEARCH
WEDNESDAY, JUNE 22, 2011
U.S. SENATE,
ON HOMELAND SECURITY
AND GOVERNMENTAL AFFAIRS,
COMMITTEE
Washington, DC.
The Committee met, pursuant to notice, at 1:34 p.m., in room
SDG50, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding.
Present: Senators Lieberman, Akaka, Pryor, Begich, Collins,
Brown, Shaheen, and Lautenberg.
OPENING STATEMENT OF CHAIRMAN LIEBERMAN
Chairman LIEBERMAN. Good morning. The hearing will come to

order. Thank you very much for being here. This is one of the afternoons and days that we look forward to, and I will say that the
younger people here in front are much better behaved than the
older people who usually fill this room, so I really appreciate it.
[Laughter.]
As a point of personal privilege, I do want to note the presence
of Secretary of War, Edwin Stanton, from the Lincoln cabinet
[Laughter.]
Oh, no, that is Kevin Kline. [Laughter and applause.]
If you have not seen The Conspirator, it is an extraordinary
movie, and Mr. Kline is really brilliant in the role of Secretary of
War Edwin Stanton, so I guess it is not a violation of our Senate
ethics rules to plug a good movie of historical content. [Laughter.]
Today, as I have traditionally done, with good cause, I am going
to turn the Chairmans gavel over to Senator Collins in recognition
of her longstanding leadership on behalf of diabetes research, particularly for children, and her truly passionate advocacy for Federal
support for that research. So without further adieu, I give the gavel
to my dear friend and colleague, the great Senator from the State
of Maine, Susan Collins.
[Applause.]
OPENING STATEMENT OF SENATOR COLLINS
Senator COLLINS [presiding]. Thank you. Thank you so much,

Mr. Chairman. I am particularly grateful that you are allowing me
to conduct this hearing. This issue is near and dear to my heart,
and this actually represents the sixth hearing of the Childrens
Congress that I have had the privilege to conduct.
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I very much appreciate the opportunity to hold this hearing to
examine what is often the devastating impact that juvenile diabetes has had on an estimated 3 million American children and their
families.
I also want particularly to welcome our distinguished witnesses
and the more than 150 children who have traveled to Washington
from every State in the country and from around the world to tell
Congress exactly what it is like to have diabetes, just how serious
it is, and why it is so important that we work together to fund the
research necessary to find a cure. I want to give a special welcome
to the delegate from Maine, 14-year-old Caroline Jacobs of
Shapleigh, Maine. She will be testifying later.
I want to also recognize Senator Shaheen, who has joined us this
afternoon, and I think Senator Lautenberg is coming, as well. Both
of them have a longstanding commitment to issues affecting children with diabetes and their families. Senator Shaheen is also my
co-chairman on the Senate Diabetes Caucus, and her daughter is
the Chair Mom of this years Childrens Congress. So we are very
delighted that she can join us, as well as our colleagues, Senator
Akaka and Senator Brown. There will be others coming in and out
today. Senators have so many different duties and obligations, but
they care a lot about this issue and others will be dropping by, as
well.
I do also want to acknowledge someone who is not able to be
with us for the first time for the Childrens Congress, and that is
Mary Tyler Moore. I talked to Mary yesterday, and she sends all
of her best wishes. She is recovering from some surgery. She is
doing really well, and I know that we miss her, but she is here in
spirit. And she is delighted that another famous American, Kevin
Kline, is joining us today, so thank you, Mr. Kline, as well.
Diabetes is a life-long condition, and it is one that does not discriminate. It affects people of every age, race, and nationality. It
is the leading cause of a lot of medical problems. Moreover, it is
estimated that diabetes accounts for more than $174 billion of our
Nations annual health care costs and one out of three Medicare
dollars. Medical costs for a child with type 1 diabetes are six times
higher than the cost for a child without the disease. These statistics are overwhelming. But what really motivated me to devote so
much energy and time to this issue was meeting with families
whose lives have been forever changed by diabetes.
I will never forget, as a new Senator in 1997, meeting with a
family whose son had diabetes. This was the first time I had really
learned about type 1 diabetes, and this little boy looked up to me
and said that he wished he could just take one day off from having
diabetes, just one day, his birthday or Christmas. But, of course,
those who have diabetes can never take a day off. But it does not
mean that you cannot accomplish great things, and I am delighted
to learn that many of you yesterday had the opportunity to meet
with Supreme Court Justice Sonya Sotomayor and hear her personal story.
It is so important that you have traveled to Washington today to
tell your stories. You put a human face on all of the statistics, and
you help us focus on what Congress can do to better understand
and ultimately find a cure for this terrible disease.
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In individuals with type 1 diabetes, the bodys immune system
attacks the pancreas and destroys the islet cells that produce insulin. An average child with diabetes will have to take more than
50,000 insulin shots in a lifetime. Of particular concern is the fact
that the incidence rate of type 1 diabetes is increasing, particularly
in children under the age of four. While the discovery of insulin
was a landmark breakthrough in the treatment of diabetes, it is
not a cure. People with type 1 diabetes face the constant threat of
developing life-threatening complications and can face a reduction
in their quality of life.
But thankfully, there is some good news. Since I founded the
Senate Diabetes Caucus, funding for diabetes research has more
than tripled and now it approaches more than $1 billion this year.
As a consequence, we have seen some encouraging breakthroughs,
and we are on the threshold of a number of important discoveries.
I talked today with several of you who have insulin pumps, for
example. Advances in technology, like continuous glucose monitors,
are helping people with diabetes control their blood glucose levels,
which is key to preventing complications.
We are also moving closer to our goal of an artificial pancreas,
which would revolutionize diabetes care. An artificial pancreas is
an external device that people with type 1 diabetes could use to do
what their bodies cannot, and that is automatically control both
high and low blood sugar levels around the clock. This new technology has the potential to dramatically improve the health and
quality of life for individuals with diabetes, and we are going to
hear from Federal officials today who will tell us about the important clinical trials that are going on that are so promising. The
Food and Drug Administration (FDA) has played a pivotal role in
moving this research forward and making the artificial pancreas
one of its Critical Path Initiatives.
We are making progress in the battle against diabetes, but this
is no time to take our foot off the accelerator. We have two choices.
We can sit back and continue to pay the bills and endure the suffering, or we can aggressively pursue a national strategy aimed at
curing this disease.
And thanks to your efforts, thanks to your coming to Washington, there is increased understanding and support in Congress
for diabetes research funding. Last year, we were able to pass legislation to extend the Special Diabetes Program for 2 additional
years, and that program represents more than a third of our Federal commitment to diabetes research. As such, it is critical to our
efforts to find better treatments, a means of prevention, and ultimately a cure.
So welcome to Washington. We are glad that you are here. Chairman Lieberman, thank you.
[Applause.]
Chairman LIEBERMAN. Thank you, Senator Collins, and really,
what I want to say is amen to everything you said, so I will be
brief.
I said at the beginning that I look forward to these hearings
every session, and I do because they are so constructive. In a government in which, too often, too little happens that is constructive
these days, this is a cause that unites people across party lines and
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has enabled us, certainly in recent years, to come together to be
supportive of diabetes research and to help facilitate some of the
really miraculous advances that have occurred in dealing with diabetes in our time.
The fact that all you young people are here is the most important
thing of all because you are the best advocates for this cause. First
off, you show everybody how well you are doing, dealing with diabetes. But the second thing is you make us all want to make the
investments that are necessary to make sure that we not only better treat diabetes, but really in your lifetime that we have a cure
for diabetes.
It is with that sense of optimism that I am really honored to welcome you and all the other witnesses here today, and I thank Senator Collins.
Senator COLLINS. Thank you, Mr. Chairman. Senator Akaka.
OPENING STATEMENT OF SENATOR AKAKA
Senator AKAKA. Thank you very much, Senator Collins. I deem

it an honor to join you here and to say thank you very much for
chairing this important hearing again on type 1 diabetes and to
share a commitment and really a passion in trying to move this
along to improve the lives and quality of life for young people and
people of our country.
I also want to welcome our distinguished panelists to this hearing who have been so committed to this issue. I also want to send
a very special aloha to those Childrens Congress delegates waiting
to testify and those in the audience, all of you who are seated here.
These are courageous young ambassadors who have traveled from
all over the country and the world to educate us. They are here to
share their stories of their own experiences, to bring a real human
dimension to the policy debate. This shows how critical research
and support is for diabetes and a hope for a cure.
Diabetes is a significant health problem in my home State of Hawaii, and it is an increasing challenge for our Nation. It is an issue
that we will look at in the Indian Affairs Committee. It will be part
of the minority health legislation that I plan to introduce. And it
is the subject of the ongoing budget and regulatory policy debate.
In this context, I am proud to support the development of the artificial pancreas, and I will continue to support funding for research at the National Institutes of Health (NIH), which gives us
the chance for better detection, better treatment, and the hope for
a cure.
All the more reason that I am so pleased to see the children here
every 2 years. They remind my colleagues and me about the struggle of living with type 1 diabetes and the importance of supporting
diabetes research.
I would like to extend a special thanks to Aaron Tsuchitori, who
traveled all the way from Honolulu with his mother to meet with
me today. If you are sitting here, Aaron, please just hold your hand
up. Oh, there you are. Yes. Thank you, Aaron, for coming all the
way from Hawaii.
I look forward to continuing to work with all of you to improve
the lives of individuals with diabetes. I am glad to be here with you
and join you in this. Thank you very much.
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[Applause.]
Senator COLLINS. Thank you, Senator Akaka. Senator Brown.
OPENING STATEMENT OF SENATOR BROWN
Senator BROWN. Thank you, Madam Chairman and Senator

Lieberman. It is good to see you all, and good to see a lot of the
children here and their families coming out and supporting diabetes research. I have the honor of having met four young people
from Massachusetts, Jackson Savage, Jordan Beals, Jonathan
Beals, and Joshua FishI see some of them out there in the audience. They gave me a lot of good information. It is something that
I have certainly been aware of and our families have been working
on long before I got to Washington, so I want to thank you for your
leadership in doing it.
I look forward to hearing all of our witnesses. I am going to be
bouncing back and forth because of other hearings, but I look forward to staying for as long as I can. Thank you.
Senator COLLINS. Thank you, Senator Brown.
I mentioned that Senator Shaheen is the co-chairman with me of
the Diabetes Caucus and has a special connection to this particular
Congress, and we are delighted to have you here.
OPENING STATEMENT OF HON. JEANNE SHAHEEN, A U.S.
SENATOR FROM THE STATE OF NEW HAMPSHIRE
Senator SHAHEEN. Thank you, Madam Chairman, and thank you

to Senator Lieberman, to both of you, for holding this hearing
today. I have a statement that I would like to submit for the
record.1
Senator COLLINS. Without objection.
Senator SHAHEEN. I know we want to get to our panelists, so I
just want to take a minute to introduce my granddaughter, Ellie,
who is a delegate here with the Childrens Congressthank you
and her mother, Stephanie, and father, Craig, who are here, and
they are co-chairing the Childrens Congress this year. I also want
to recognize Abigail Lore and her mother, Jeanine, who are from
Merrimack, New Hampshire. Thank you both for being here, as
well. And thank you to all of the families and all of the delegates
who are here today.
I am very happy and proud to be able to join you in advocating
for research for a cure for juvenile diabetes and also for moving forward as quickly as we can with the development of an artificial
pancreas.
So again, thank you all very much for being here.
[Applause.]
Senator COLLINS. Thank you, Senator Shaheen.
Senator Lautenberg, we are delighted that you could join us
again this year. I mentioned in my opening statement that you,
too, have a personal connection to diabetes and have demonstrated
tremendous leadership in this area.
1 The
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OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, A U.S.
SENATOR FROM THE STATE OF NEW JERSEY
Senator LAUTENBERG. I have a granddaughter, also, that I am

fortunate enough to have who has diabetes. And I want to say
thanks to the Chairman for inviting me here today. It is a personal
issue for me, and I appreciate the chance to work with you, Senator
Lieberman, but particularly with Senator Collins, our colleague
from Maine. She has been so diligent, so persistent, so determined
to help our country by making sure that those with diabetes can
conduct their lives with a decent attitude and participation in all
of the activities.
When my granddaughter was here during the Obama inauguration, I saw that she looked pale. I saw that she seemed tired, 12
years of age, and I said to my daughter, Is there something wrong
with Maddie? And she said, I do not think so, Dad, but some
signs tell me we have to get her to a doctor. Therefore, they did
that, and we visited her in the hospital a day after she got back
to Florida, where she lived. She had her first treatment with insulin. She was bright. She was positive. She was hopeful. And I
thought, all this devastation that came upon us when we learned
that she had diabetes. And I can tell you, that granddaughter of
mine is now on a soccer team that was running for the State championship in Florida. She is never too tired to take on an activity.
And she has been an inspiration to my life, just as all of you are
an inspiration here. You do not know how much you do for us. You
know that we try to do things for you, but you do more for us when
we see your faces and we see your smiles and we see your parents,
and we know that life is good for you and we are going to keep on
working to make it better.
I thank our friends here and all of my colleagues for participating in this important hearing. Thank you, Senator Collins.
[Applause.]
Senator COLLINS. Thank you very much, Senator Lautenberg.
Senator Pryor, welcome.
OPENING STATEMENT OF SENATOR PRYOR
Senator PRYOR. Thank you, and thanks for having me. I think
everybody understands this now, but if we do not get it, I want to
make sure that everybody understands what a tremendous advocate you have in Senator Collins. Let us give her one more hand.
She is great.
[Applause.]
Senator PRYOR. I really just want to say one more thing. I know
that Davis Moore from Arkansas is here. Thank you for being here,
and all of you who are wearing the blue shirts, you are making a
difference. Thank you for coming to Washington, and thank you for
fighting the good fight. It is certainly a fight worth fighting, and
thank you for all the things you represent and all the great things
you are going to accomplish. Thank you.
[Applause.]
Senator COLLINS. Thank you very much, Senator Pryor.
Leading off our first panel this morning is Academy Award winning actor and longtime Juvenile Diabetes Research Foundation
(JDRF) advocate Kevin Kline. One of our countrys finest film and
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stage actors, as Senator Lieberman mentioned, Mr. Kline may have
been virtually unrecognizable in his recent appearance as Edwin
Stanton, the Secretary of War, in the movie, The Conspirator, but
he is no stranger to us. He testified before our Committee 10 years
ago at our 2001 hearing, and I am delighted that he has made a
return performance, an encore, I guess I will call it, because I look
forward to hearing his perspective on the progress that has been
made during the past decade and the road ahead.
So welcome. We are delighted to have you here.
TESTIMONY OF KEVIN KLINE,1 CELEBRITY ADVOCATE COCHAIRMAN, JUVENILE DIABETES RESEARCH FOUNDATION
Mr. KLINE. Senator Collins, thank you. Senator Lieberman,

thank you, and thank you for the nice mention of The Conspirator, and my performance as a historical figure. Members of
the Committee, thank you all for inviting me to appear today with
this distinguished panel and amidst this collection of such remarkably poised, self-possessed, quiet, but ultimately very vocal delegates, I hope.
Ten years ago, as you mentioned, I had the honor of joining Mary
Tyler Moore and the 100-plus delegates at the 2001 JDRF Childrens Congress. Since then, I am happy to report that we have
made remarkable progress in understanding this disease. We are
many steps closer to a cure, and even as we are gathered here
today, new tools are being developed to improve the day-to-day
management of type 1 diabetes. But we still have a ways to go,
which is why we are here now, not only championing the science,
but pushing to accelerate programs.
Today, these great young delegates are getting the attention that
they so richly deserve. But I would like to take a few moments to
recognize all of the parents, siblings, and other special people that
these young advocates have brought with them today. They know
firsthand the challenges that we face as we shepherd our children
and loved ones through life with the added burden of diabetes.
You see, when a child is first diagnosed with type 1 diabetes, the
parents are thrust immediately into the additional roles of doctors,
nurses, nutritionists, and even psychologists. They are on duty 24
hours a day, 7 days a week, 365 days a year, monitoring their
childs blood sugar levels and physical activity, counting the carbohydrates in their meals and snacks, calculating insulin dosages,
giving injections, as well as managing the emotional stresses which
come from dealing with the daily rigors of this disease.
Each day, as I am sure these children will testify to, brings its
own unique challenge to control blood sugar levels, even with the
best of plans and the use of the latest technology. It is not unusual
for parents to wake up routinely in the middle of the night to check
their childrens blood sugar to make sure it did not become too high
or so low as to result in a seizure or a coma or worse. These blood
sugar emergencies are all too common, and a number of parents
here have had to call 911 to save their childrens lives.
Many parents have become their childrens advocates in the fight
to cure diabetes by joining JDRF. As JDRFs National Walk Chair1 The
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person, I had the great pleasure of rallying people across the country to join the JDRF Walk to Cure Diabetes, and I am happy to
report that thanks to the outpouring of enthusiastic support, we
have raised millions of dollars with the walk. JDRF has put this
money to work in a direct and efficient manner to support research
for better treatments, prevention, and ultimately for a cure for type
1 diabetes.
The Federal Government has also played a critical role in the
fight to cure diabetes, in particular with the strong bipartisan support for the Special Diabetes Program. I thank you, Senator Collins, for your leadership, and I thank your colleagues in the Senate
and House who recognized the great return on investment from the
Special Diabetes Program and who supported the 2-year $300 million extension this past December.
Together, JDRF and the Federal Government have made and
will continue to make powerful partners in advancing research to
cure, treat, and prevent type 1 diabetes.
Since I testified here before this panel 10 years ago, more than
40 of the genes have been discovered which put people at risk for
type 1 diabetes. Numerous therapies to halt the autoimmune attack which causes type 1 diabetes are being tested in human clinical trials. New therapies have also been shown not only to halt the
progression of diabetic eye disease, but also to improve the vision
in those who already suffer from it. And finally, the artificial pancreas has gone from being merely a theory to a cutting-edge technology that has been shown in early trials to prevent dangerous
low and high blood sugars.
Apart from finding a cure, the artificial pancreas represents a
watershed moment in the management of diabetes and happens to
also be a parents dream come true. Imagine, if you will, going to
bed at night without having to worry about dangerous nighttime
high or low blood sugar levels, or knowing that your child will have
a great day at school without the burden of pricking his or her fingers, counting carbohydrates, taking the right amount of insulin,
and treating high and low blood sugars, or just getting so caught
up in being a kid and forgetting to do some of these things and
coming home from school dangerously ill. Best of all, imagine
knowing that your child will live a long, productive life since these
artificial pancreas technologies have the potential to keep him or
her healthier longer, forestalling or completely circumventing the
devastating complications until a cure is found.
I know the Food and Drug Administration has made the artificial
pancreas a priority, and I commend Commissioner Margaret Hamburg for her leadership. But there is more that the FDA needs to
do. Many of these children here today are, in fact, wearing the components of what will ultimately constitute an artificial pancreas,
namely, insulin pumps that deliver insulin as well as continuous
glucose monitors which give blood sugar readouts every few minutes. The challenge that we face now, however, is to get these devices, which do not yet work together automatically, to talk to each
other and to control the blood sugar levels.
In other countries, there are devices now available that take the
first step in this process, by automatically shutting off the insulin
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pump when someone is going low. This is an important step and
one that we need to take in the United States right now.
And we can do more than that. JDRF and federally funded research have, in hospital settings, tested artificial pancreas technologies that automatically turn insulin both on and off, and the
results have been overwhelmingly positive. The next step is testing
these artificial pancreas devices in real-world settings. To do this
without delay, however, the FDA needs to provide clear and reasonable guidance. Many of the worlds best diabetes researchers
and leading clinician organizations have joined together with JDRF
to propose artificial pancreas guidance to the FDA, and the majority of the Senate and the House have urged the FDA to give this
proposal immediate consideration.
We now need the FDA to act. Parents who are up every night
and worrying every day about their children simply cannot afford
to wait any longer. It is past time for the artificial pancreas technologies to be tested in real-world settings. We urge, we implore
the FDA to issue draft guidance for public comment on the artificial pancreas so that outpatient trials can begin and the oppressive
burdens of type 1 diabetes can be lifted from millions of Americans
as soon as possible.
Thank you for the opportunity to participate in the hearing
today, and I would be pleased to answer any questions that I can.
[Applause.]
Senator COLLINS. Thank you very much for that excellent testimony, Mr. Kline.
Next, we will hear from Dr. Griffin Rodgers, who is the Director
of the National Institute of Diabetes and Digestive and Kidney Diseases at NIH. He will bring us up to date on the advances in research, and I also hope that he will provide some examples of the
research that is specifically supported by the Special Diabetes Program. Dr. Rodgers, welcome.
TESTIMONY OF GRIFFIN P. RODGERS, M.D.,1 DIRECTOR,
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND
KIDNEY DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. RODGERS. Thank you very much. Mr. Chairman, Senator Collins, and Members of the Committee, as the Director of the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), I thank you for the invitation to testify at this hearing
on type 1 diabetes.
And on behalf of NIDDK and the other institutes and centers at
NIH, I am pleased to report that we are vigorously pursuing research to prevent, treat, and ultimately cure type 1 diabetes and
its complications. Through collaborative and coordinated research
efforts with our partners, including the Juvenile Diabetes Research
Foundation, and with the support of the Special Statutory Funding
Program for Type 1 Diabetes Research, we are making critical
steps toward these goals that I have outlined.
Now, before I highlight some of the exciting advances, I would
like to acknowledge the important contribution of my fellow wit1 The
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nesses. Mary Tyler Moore, here in spirit, you continue to motivate
us with your unwavering devotion to improve the lives of others
with type 1 diabetes.
Kevin Kline, you tirelessly raise awareness of the disease and
promote efforts toward a cure.
I am also pleased to share the table today with Dr. Zimliki, who
will describe the complementary efforts of the FDA to advance the
artificial pancreas.
I would also like to acknowledge the children, parents, and families who will testify and who sit in this room proudly representing
their States and the many other Americans with type 1 diabetes.
Many of you have participated in clinical trials to help improve diabetes care, not only for yourself, but for future generations. We are
inspired by your dedicated efforts and your enthusiasm.
Now, research in type 1 diabetes has made a tremendous impact
on the health and quality of life of people with this disease. I will
reference three handouts during my testimony to illustrate these
points, and these handouts are attached to the copies of my written
testimony.1
On the first handout, a bar graph shows that the survival rate
for people with type 1 diabetes has dramatically improved over
time. For people diagnosed, for example, in the 1950s, represented
by the blue bar on the far left side of the graph, only about 70 percent survived for 25 years with the disease. This number has dramatically increased to about 95 percent for people diagnosed in the
1970s, represented by the purple bars on the far right side of the
graph. The outlook is even brighter for todays children, due to improvements in diabetes care and technologies. Still, the burden of
living with diabetes, as my colleagues have mentioned, is enormous, and so it is critical to build on research progress to find ways
to prevent and cure the disease.
On the second handout, you will see that even before type 1 diabetes becomes apparent, the immune systems of people who will
develop the disease are destroying their insulin-producing beta
cells, leading to a decrease in beta cell mass, and I will describe
how the NIH is focusing our research on different stages of the disease progression.
Now, as indicated on the far left of this graph, understanding the
causes of type 1 diabetes is essential to our preventing the onset
of autoimmunity, a preclinical sign of the disease, and of the disease itself, and significant progress has been made in unraveling
the genetic causes of type 1 diabetes. As was mentioned, just a few
years ago, we only had three genes that we understood contributed
to the risk of the disease. Today, due to the efforts of the Type 1
Diabetes Genetics Consortium and other researchers, nearly 50 genetic regions have been identified.
We know that there are likely factors that exist in the environment that interact with these genetics to turn disease risk into disease reality. And because the genetic risk for type 1 diabetes is
now well characterized, we can identify those at risk and follow
them, and this has allowed us to embark on a bold, long-term, systematic study to identify these environmental factors.
1 The
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This study, the Environmental Determinants of Diabetes in the
Young (TEDDY), has enrolled over 8,600 newborns with high genetic risk for the disease, and we plan to follow them for 15 years.
We will be collecting biological samples and information about their
lives. Identification, for example, of an infectious agent that triggers this autoimmunity could lead to a vaccine to protect against
this disorder. On the other hand, if we find that dietary factors protect from or contribute to the development of the disease, we can
recommend changes to infant feeding practices. TEDDY may also
shed light on other autoimmune diseases, like celiac disease.
The NIH also supports research in preclinical and early disease
stages, as shown by the blue and red arrows. Today, blood tests can
accurately identify relatives of people with type 1 diabetes who are
at high or moderate risk of developing the disease within 5 years.
This important advance has enabled Type 1 Diabetes TrialNet to
launch clinical trials of promising prevention strategies to stop the
autoimmune attack.
It is also important to identify ways to halt or reverse disease
progression soon after onset to preserve any remaining beta cells.
In collaboration with the Immune Tolerance Network, TrialNet is
also conducting trials of promising therapies in newly diagnosed
patients.
Now, the third handout continues along the spectrum of disease
progression, and this next stage of the disease research, shown in
green, focuses on people with established type 1 diabetes. A high
priority for research at this stage is the development of new tools
and technology to help people improve their blood glucose control
because that can reduce disease complication by up to 70 percent.
Certainly, an artificial pancreas to automatically link glucose monitoring with insulin delivery can make a positive impact on peoples
health and their quality of life. NIDDK is supporting innovations
in technology critical to the development of an artificial pancreas.
Working closely with our partners at the FDA, we are pursuing research to test artificial pancreas technology and ensure that it is
safe and effective.
In recent advances, scientists developed and are testing a bi-hormonal closed-loop artificial pancreas, one that delivers not only insulin, but a counterbalancing hormone, glucagon, to more finely reproduce the activity of the human pancreas. In another recent
study, researchers looked at overnight closed-loop insulin delivery
following two different real-life dinner scenarios. Testing closedloop technologies in real-life situations is really a key step toward
moving this technology out of the clinic and into the real world.
A major goal of research at the next stage, shown in purple, is
to investigate ways to replace the destroyed beta cells and restore
beta cell function, and one approach to replace these cells is
through islet transplantation, and the Clinical Islet Transplantation Consortium is conducting trials to study and to refine this
therapeutic strategy. Scientists like those in the Beta Cell Biology
Consortium are also pursuing strategies to replace islet cells by
growing cells in the laboratory for transplantation into people or by
expanding their remaining beta cells or by coaxing other types of
cells in the pancreas to become beta cells.
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Finally, until prevention or cure of type 1 diabetes is possible, research toward preventing, arresting, and reversing the complications of the disease is critically important, shown on the far right
of that graph. Just recently, we saw the biggest advance in diabetes eye disease treatment in 25 years. A landmark study from the
Diabetic Retinopathy Clinical Research Network found that patients who received a combination of a drug and standard laser
therapy showed substantial vision improvement after 1 year. Advances like these in treating diabetic complications also benefit patients who have type 2 diabetes and are at risk of these complications, as well.
Hundreds of thousands of individuals have participated in research supported by the Special Diabetes Program. Remarkably,
nearly 30 years after one pivotal trial study began, about 95 percent of the participants in this landmark trial, which showed that
glucose control dramatically reduced type 1 diabetes complications,
continue to participate in a follow-up study known as Epidemiology
of Diabetes Interventions and Complications (EDIC), and as a result of their commitment, this long-term investment in research
continues to identify ways to improve the health of people with diabetes.
I am grateful for the opportunity to share with you just a few
examples of the many recent advances in ongoing research in type
1 diabetes. We continue to be inspired by the dedicated efforts of
individuals affected by type 1 diabetes and by the organizations
like JDRF that represent them. We look forward to continuing our
partnership with JDRF and our sister Federal agencies on research
to combat type 1 diabetes and its complications, and we will continue to be diligent in our fight against type 1 diabetes to help all
the children here and the many Americans whom they represent
today, and we will strive to improve their quality of life with the
ultimate goal of curing this disease.
Thank you, Mr. Chairman and Senator Collins, for your leadership in calling for this hearing to continue to bring attention to the
importance of type 1 diabetes research and for your continued support of NIH research. I will be pleased to answer any questions
that you might have.
[Applause.]
Senator COLLINS. Thank you, Dr. Rodgers.
Our last witness on this panel, before we hear from the children,
is Dr. Charles Zimliki. He is the Chairman of the Food and Drug
Administrations Artificial Pancreas Critical Path Initiative. There
is tremendous interest and excitement about this research and
technology, and I look forward to hearing your statement.
TESTIMONY OF CHARLES ZIMLIKI, PH.D.,1 CHAIRMAN, ARTIFICIAL PANCREAS CRITICAL PATH INITIATIVE, CENTER FOR
DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG
ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dr. ZIMLIKI. Well, I share that excitement, as well. Madam

Chairman and Members of the Committee, I am Dr. Chip Zimliki,
1 The
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Chairman of the Artificial Pancreas Critical Path Initiative, located
within the Center for Devices and Radiological Health at the FDA.
I would like to thank the Committee for the opportunity to discuss the artificial pancreas system and what the FDA is doing to
assist in the development of these critically needed and potentially
life-changing devices. As a person living with type 1 diabetes, I am
personally and professionally committed to seeing this important,
novel medical device approved in the United States.
And I just want to go offline here and say, Mr. Kline, I fully support the proposal about issuing guidance, and I believe the FDA
will submit guidance for all types of artificial pancreas systems before December of this year.
[Applause.]
Dr. ZIMLIKI. Diabetes is a disease that affects the entire family,
especially when a child is diagnosed. I know this because I was diagnosed with diabetes when I was 13 years old. When I was diagnosed, the technology was a great deal different. They were just
coming out with glucose meters, and it took much longer than it
does today to obtain a blood glucose measurement. Technology has
come a long way, and I am very grateful for that.
But even now, with todays technology, we still must prick our
fingers to test our blood multiple times a day, and over time, it can
really hurt. I am sure the children here can attest to that. We must
also calculate insulin doses, administer necessary insulin via syringes or infusion pumps in order to lower blood glucose, and, as
always, we have to be prepared for the inevitable lows and highs
associated with diabetes. I admit, it is really tough being a diabetic.
While great strides have been made in diabetes management,
current treatment is constant and pervades all aspects of a persons
life, presenting a particularly arduous burden for children and
their parents. An artificial pancreas system is an innovative device
for treatment of type 1 diabetes that, once fully developed, will
automatically monitor blood glucose and administer appropriate insulin doses. This life-changing technology will positively impact diabetic patients health and quality of life.
As a person with diabetes, I am acutely aware of the benefits an
artificial pancreas system will provide. I say will because I am
highly optimistic that industry, researchers, and the FDA will
bring this device to market. An artificial pancreas system will
allow people with diabetes, especially children, to live active lives
without the constant need to adjust glucose levels.
While I know the potential benefits are enormous, an artificial
pancreas system is a significant risk device, meaning it presents a
potential for serious risk to the health, safety, or welfare of the patient. If not properly designed, use of an artificial pancreas device
in an outpatient setting can place patients at significant risk because the device controls the administration of insulin. As such, an
Investigational Device Exemption (IDE) from the FDA is needed to
allow the investigational device to be used in a clinical study.
Currently, the FDA has approved over 17 clinical studies for artificial pancreas systems at various levels of development, and we
have seen promising results. The FDA is helping advance the development of an artificial pancreas system by prioritizing the re-
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view of IDE studies, fostering discussion, shortening study and review times, and providing clear guidelines and a path to market for
industry.
In 2007, the FDA created the Artificial Pancreas Critical Path
Initiative, bringing together a multi-disciplinary group of scientists
and clinicians from the FDA and NIH. One of the major goals of
this initiative is to identify roadblocks and possible solutions to
streamline the regulatory process. A shining example of this effort
was how the FDA worked with the developer of a software program
so that researchers working on an artificial pancreas system could
test control algorithms and use the results in support of regulatory
submissions. This important software tool enables researchers to
quickly test artificial pancreas control algorithms and is accepted
in place of costly and time-consuming animal studies. This effort
saved investigators 6 months to a year in clinical study time and
expedited the transition to human trials.
The FDA also encourages researchers to contact the agency early
to discuss clinical study plans and get informal feedback that can
improve their study designs and facilitate the review process. This
quick, informal feedback can help investigators develop better and
more complete study plans for the FDA review. When investigators
submit their final study plan, the FDA gives these submissions the
highest priority and works interactively with investigators to move
them quickly and efficiently through the review process. Questions
and research challenges are often quickly resolved, helping researchers start their study sooner.
The FDA guidance and industry standards help manufacturers
and researchers understand the minimum requirements for making
a device that is safe and effective. This helps them make the best
use of resources and streamlines the regulatory review process. We
agree with JDRF and others that guidance to industry is useful for
product development.
On June 22, 2011, the FDA issued draft guidance that will help
advance the development and approval of an artificial pancreas
system to treat type 1 diabetes in the United States. This guidance
document addresses an early version of an artificial pancreas
system known as a Low Glucose Suspend (LGS) system. The LGS
system can help reduce or lessen the severity of hypoglycemia by
temporarily reducing or stopping delivery of insulin. Patients using
this kind of system still must test their glucose levels on a regular
basis with a glucose meter and give themselves insulin. The draft
guidance provides recommendations for those planning to develop
and submit for FDA approval an application for an LGS system.
The FDA is also seeking input from industry, researchers, and
the clinical community on the draft LGS guidance. Specifically, the
agency is interested in feedback about the types of clinical studies
that should be conducted and what their target outcomes should be
to demonstrate safety and effectiveness. Your input is also very
welcome.
The FDA is also working on the second draft guidance, as I discussed. The FDA has been working with research communities,
such as JDRF, to expedite this guidance, and we have promised the
publication of the draft guidance by the end of this year.
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Finally, the FDA is working with NIH and other interested parties in planning the next artificial pancreas workshop, which will
focus on developing better technology for creation of a more accurate and reliable artificial pancreas system. This is the system that
you can just put on and not worry about. I cannot wait for that
day.
The FDA is fully committed to the development of an artificial
pancreas to meet this critical health need. It is the goal of the
agency to provide a clear pathway for manufacturers to provide
people with diabetes with innovative, safe, and effective medical
devices to treat their disease.
Madam Chairman, this concludes my formal remarks, and I will
be pleased to answer any questions the Committee may have.
Senator COLLINS. Thank you, Dr. Zimliki.
[Applause.]
Senator COLLINS. Thank you so much for your testimony.
We are going to do a 6-minute round of questions so that we can
get to the next panel. We could keep you here all day.
Dr. Zimliki, it is great news that you have given us today, and
I saw the guidance on Monday about the draft guidance. In early
May, 59 of us signed a letter that I spearheaded that encouraged
the FDA to move forward with issuing guidance that would enable
clinical trials for testing the artificial pancreas to move from an inpatient to an outpatient basis. Does this guidance help us along to
achieve that goal of moving to the outpatient guidance?
Dr. ZIMLIKI. Yes, indeed, it does. This is the complete package
guidance. This will help academicians start their investigations, get
them approval for the clinical studies in the in-clinic, and it outlines what type of information the FDA needs to assure safety as
we transition from the in-clinic to the outpatient settings.
Senator COLLINS. And on a related question for you, I have
heardand there are some delegates from Canada here today
that the Low Glucose Suspend system technology is available now
in Canada and other parts of the world. Could you explain to us,
and I am not trying to put you on the hot seatwell, maybe I am
trying to put you on the hot seat [Laughter.]
But why is it not available here if it is available next door in
Canada?
Dr. ZIMLIKI. Well, it is hard to draw comparisons across the various regulatory agencies around the world. The FDA has to operate
within U.S. law, which states medical devices must be safe and effective.
I will give you an example. The European Unions law states that
medical devices need to be safe and perform. That might not sound
like a big difference, but there is a significant difference between
the two, and I will use the Veo system as the example. This is
going to be a long answer, I am sorry, Senator Collins.
The Veo system shuts off insulin when the continuing glucose
monitoring (CGM) value is low. To evaluate the performance of
that, all you need to do is show that the insulin pump shuts off
when the sensor reads low. That is a perfect engineering question
that can easily be tested on the bench side. The FDA agrees that
type of performance is needed.
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But what the FDA also needs for effectiveness is to know what
happens to the patient when the pump actually turns off. That information is critical because it allows the prescribing clinician to
look at the information that is provided in that clinical study and
determine whether or not the patient can use this device beneficially.
With regard to the Veo system, I will say Medtronic and the FDA
have been continually working together. The Aspire study is an ongoing study to provide sufficient safety data within the United
States, and it is the hope of the FDA that this safety data will
allow the transition to an outpatient setting and finally approval
of that device.
Senator COLLINS. Thank you.
Dr. Rodgers, last year, Congress passed legislation extending the
funding for the Special Diabetes Program through September 2013.
How important is it for Congress to do multiple years as opposed
to year-to-year renewals of funding? Does that have an impact on
the kinds of studies that you can fund?
Dr. RODGERS. Well, Senator, we were very pleased to receive that
multi-year renewal of the Special Diabetes Program through fiscal
year 2013. The multi-year renewal greatly improves the planning
process that goes on in NIDDK. For example, many clinical studies
take multiple years to perform, and it would be very difficult, if not
impossible, to start such a multi-year clinical trial without knowledge of whether the funds will exist in future years to continue
those types of studies.
One area that we are absolutely looking at is to bring new people
and new talent into this field. For example, in the artificial pancreas field, we have obviously very dedicated and talented clinicians and we have people in the device industry, but what needs
to link them or, as my colleague Mr. Kline says, to actually get
them to talk together are bioengineers. And so with this multi-year
funding, we are trying to put in training efforts to bring bioengineers into this field, and training occurs over long time horizons,
and therefore, multi-year funding is also critically important for
them.
One final thing that I would say is that as we move toward the
artificial pancreas, clearly, we would recognize that there might be
some issues related to compliance, and so now we are trying to get
people who have been previously engaged in behavioral science to
tell us what particular challenges we might face, and we are trying
to get them involved in research in diabetes. So training and bringing in new talent are critically important, and multi-year funding
greatly assists in that regard.
Senator COLLINS. Thank you.
Mr. Kline, you mentioned in your statement that when there is
a diagnosis of type 1 diabetes, it affects the whole family and involves the whole family. You also talked about the fact that there
are different challenges at different ages. Could you, having lived
with this for quite some time now, elaborate on the impact on the
family and the challenges at different ages, from toddler to teenager?
Mr. KLINE. Well, it affects the entire family. It transforms the
entire family, and it changes with age and the various vicissitudes
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that the disease can go through. Suddenly, in the teenage years
with the hormones being what they are, there are chaotic glucose
levels.
Senator COLLINS. People are agreeing.
Mr. KLINE. And it is just a vast improvisation of figuring out how
to react to this. Is this a real high number or is this the hormones?
It is not unlike life that way, I guess, trying to find what is the
absolute cause for any particular symptom.
But, obviously, when a child is diagnosed at 6 months, he cannot
tell you that he is feeling low or feeling high. It is too horrible to
imagine. It does get easier. All things being relative and given our
human nature and our marvelous adaptability, we can adapt to a
surprising number of things. Children get more and more used to
it, get more and more on top of it, depending on the nature of the
child. There are some type A personalities who are just all over
their diabetes and are really in control of it, and there are others
who are more in denial of it, who do not want to be bothered with
it, who want those days of not having diabetes that you spoke of
earlier, just one day, and sometimes they will just take that day,
even though it is not an officially appointed day for such behavior.
[Laughter.]
But they will take it upon themselves and havoc will be wreaked.
It gets easier and harder, but most of all, it does not stop. When
your child gets older, goes off to college, you are still calling incessantly. You are still checking up. You are still worried. You are still
making trips at strange hours of the night to deal with sudden insulin emergencies. It is moment to moment, hour by hour, day to
day. It is ongoing, which is, I think, why JDRF wants to stress the
urgency and the need to keep the research going and to get the artificial pancreas done because, I think, as these marvelous children
can attest, tomorrow is going to be here sooner than we would like
and we would like to have the artificial pancreas tomorrow, please,
or yesterday, or today.
Senator COLLINS. Thank you. Senator Brown.
[Lights go out.]
Senator BROWN. That happens regularly with me. [Laughter.]
It is a conspiracy.
Mr. KLINE. I guess we have not paid our electric bill.
Senator COLLINS. You are not in Massachusetts, so I do not know
why this happened.
Senator BROWN. It is following me everywhere.
Mr. KLINE. I asked for that. It is a very dramatic device called
blackout. [Laughter.]
Senator COLLINS. That was very dramatic.
Mr. KLINE. Thank you.
[Laughter and applause.]
Mr. KLINE. That is what this button is.
Senator COLLINS. That was a good stage trick, Mr. Kline.
[Laughter.]
Senator BROWN. That was perfect.
Mr. KLINE. How do you follow that?
Senator BROWN. Everyone is awake now. [Laughter.]
Mr. Kline, thank you very much for coming and offering your
star power to a cause such as this. I think everybody I know has
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some type of experience with diabetes, whether it is in their own
family or with their friends, so we really would like to just thank
you for taking time out of your schedule. I think we all respect
your acting ability and what you also do with philanthropic causes,
so thank you.
Dr. Zimliki, I have 225 medical device companies in Massachusetts. I visited Medtronic and others, and the biggest challenge is
the fact that there is a tremendous amount of delay and inefficiency within the FDA. I have met with Commissioner Hamburg,
and I will say that she recognizes that problem, and she is making
great efforts to try to streamline, consolidate, and eliminate a lot
of that duplication. The No. 1 issue I find in Massachusetts and as
I travel throughout the country is you have a company that is trying to make a difference for people like this, and they are marching
along with a checklist, and then in the middle of the checklist, they
have to go back to square one at tremendous cost. And I look at
those medical devices that are approved in Ireland and Canada,
and our companies are saying to me, as their U.S. Senator, why are
we not being approved here in Massachusetts and in the United
States?
[Applause.]
Senator BROWN. So on the one hand, I have been very critical of
the FDA and its delay because there needs to be consistency, stability, and certainty in the process for development and the ability
to find cures.
On the other hand, I have also been very public in saying thank
you to her and the agency for finally realizing that there is a problem and trying to fix it. So I wanted to let you know that, and I
am wondering, how are you finding the new leadership and that
new process? Is it moving along as expeditiously as you would like?
It is a softball. [Laughter.]
Dr. ZIMLIKI. And I am due for promotion, too. [Laughter.]
Senator BROWN. Well, go for it.
Dr. ZIMLIKI. Absolutely. [Laughter.]
Yes, absolutely. We have new leadership, and Dr. Jeffrey Shuren
has certainly said that there is room for improvement for the review process by increasing predictability, consistency, and transparency. There is an entire action plan in place regarding the improvements in the review process.
My focus here today is about the artificial pancreas, and I am
very happy and pleased to know that Dr. Hamburg and Dr. Shuren
give me their fullest support, and we are going to make sure that
this device gets approved. We are hopeful that this guidance improves transparency so that a company like you referenced does not
go halfway through the development process and then have to start
back at square one.
Senator BROWN. Right. Well, thank you. It is a tremendous job
killer in my State and throughout the country.
I think you stated that you want a device that performs precisely, reliably, and individually as a unit. What steps are you taking to ensure the quality and safety of these systems in the clinical
trials, specifically in your Phase II guidance?
Dr. ZIMLIKI. Just give me one second here.
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Senator BROWN. You thought you were going to get easy questions.
Dr. ZIMLIKI. The Phase II guidance will adopt some of the information from JDRF. Now, granted, the Phase II guidance, which I
will call the more advanced artificial pancreas guidance, is using
some of the information that the clinical panels recommendation
by JDRF submitted to the FDA. It is a three-phased approach, and
the idea would be to understand the device in the clinic, then transition into a more realistic version of home life except under mitigation or supervision, such as a diabetes camp. I am sure most of
these people here have been to a diabetes camp, is that correct?
[Chorus of yes.]
Dr. ZIMLIKI. Thank you. I like it, too. Then the last phase would
be the transition to the outpatient setting. That is consistent with
the recommendations from the JDRF as well as most of the medical community.
The guidance is still under development, and we are going to be
finalizing and publishing it in December of this year.
Senator BROWN. Dr. Rodgers, what is NIHs current role in supporting the FDA in this process in terms of how do you foresee
NIHs role changing in the current months, and will you be facilitating the transition to clinical trials with the translational research?
Dr. RODGERS. Yes. Under the auspices of the Diabetes Mellitus
Interagency Coordinating Committee, we regularly meet with not
only our colleagues at the FDA, the Centers for Disease Control
and Prevenion (CDC), and other Federal agencies, but other institutes within NIH that have a role to play in diabetes research. We
work very closely with Dr. Zimliki and his colleagues in an Interagency Artificial Pancreas Working Group.
In fact, just a few months ago, we held a meeting in conjunction
with the JDRF, and we are actually planning to have a follow-on
meeting in the fall of this year to develop a working understanding
of what are some of the challenges, what are the other groups that
we need to bring into the question, particularly bioengineers, mathematicians, theoreticians, to try to assist us in moving more expeditiously along this pathway.
So we have an essential role. We have been working together
very closely. This is not only with the FDA and the NIH, but the
meeting in the fall of this year will also involve the JDRF, as well.
Senator BROWN. Very well. Madam Chairman, you surprise me
more and more each day. I was not aware until this year that you
were advocating for this cause, so thank you for that. Will there
be an opportunity to submit questions to our panel members?
Senator COLLINS. Absolutely.
Senator BROWN. I just want to say, also, thank you to our panel
and all the parents and children who came. It means a lot. I am
going to be bouncing back and forth as I have done, so I will try
to get back for the children. Thanks.
Senator COLLINS. Thank you. Senator Shaheen.
Senator SHAHEEN. Thank you, Madam Chairman, and thank you
to all of our panelists this afternoon.
Dr. Zimliki, as you are aware, I share the frustration that both
Senator Collins and Senator Brown have expressed about the pace
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at which the FDA has moved on getting the guidance out on the
artificial pancreas. I am pleased to hear you say that you expect
that to happen by December, but I wonder if you could then outline
what the next steps are once that happens, on the way to getting
approval for the artificial pancreas.
Dr. ZIMLIKI. Can you clarify which artificial pancreas type system you are asking about?
Senator SHAHEEN. I know there are a number of those systems
in development
Dr. ZIMLIKI. Right.
Senator SHAHEEN [continuing]. And I am interested in seeing
something that can be commercially available, on the market, that
will be approved by the FDA and be safe and available to my family and all the families who are here. And I do not particularly care
who the producer of that system is.
Dr. ZIMLIKI. I was just asking for clarification on the type. There
are many types of artificial pancreas systems. We talk about the
Veo system, which is a Low Glucose Suspend system. The agency
believes that this is a type of artificial pancreas that should be on
the market sooner than later.
Senator SHAHEEN. I appreciate that. I think for many of the people in this audience, they do not see that as the artificial pancreas
that we are really hoping will be on the market. I agree, that is
a step in the right direction, but as has been pointed out, that device is available on the market in other countries, and we would
like to see not only that device available here, but to go to the next
step, to have a continuous system available for people.
Dr. ZIMLIKI. Is the question that you would like to know the time
line?
Senator SHAHEEN. I would like to know what steps the FDA sees
that it is going to require in order to move forward. You said you
expect to see draft guidance on that by December. So then what
happens? I wonder if you could just outline the steps.
Dr. ZIMLIKI. The draft guidance is out for public comment for
anywhere between 60 and 90 days, and we look forward to all the
comments from the scientific community to help shape and modify
that guidance in the hopes of making it final. It will become a
guideline to an approval package.
Now, the timing and the ability to get a device approved depends
on a lot of people. It really depends on the FDA being transparent
and providing this guidance so that industry can follow it and actually conduct studies. That takes time, and it takes people like you
out here in the blue shirts to volunteer and be part of these studies.
The process is that by probably mid-year or next year, the guidance will be finalized. Even when it is not finalized but published
in December, industry can start developing their process in getting
to an outpatient study and a pivotal study, which will lead to an
approval.
In November 2010, I believe, one of the JDRF-sponsored investigators at our Artificial Pancreas Workshop estimated anywhere
between 2013 and 2014 before getting to a pivotal study. There is
a lot of information that needs to be built up to get to that final
stage for product approval, and it is contingent on the research for
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glucose sensing. We need better sensors. We absolutely need more
reliable continuous glucose monitor sensors, and we need the research to really find out how to make that happen.
Senator SHAHEEN. Dr. Rodgers, you talked about the role that
NIH has with the FDA. Can you talk about how NIH can be helpful in moving this process forward.
Dr. RODGERS. Well, Senator, in addition to working on a collaborative and coordinating basis, some of the vital research that Dr.
Zimliki is mentioning is something that we see as our major contribution in moving the process forward and making it in fairly reliable and practical steps. Just recently, as I had mentioned, for example, in a closed-loop system, not only using insulin, but to try
to more closely replicate what the pancreas does, scientists who we
funded used two hormones, both insulin and the counter-regulatory
hormone glucagon, to see whether one could get more precise blood
glucose control over time. But again, these are done in a clinical
setting.
Ultimately, for this to be effective in the real world, we have to
try to replicate that to a great extent, and this is why the more recent studies are actually looking at two different meal scenarios,
particularly at night, because that would be a critical step, if we
could use this closed-loop system so that parents do not have to get
up in the middle of the night to check their childs blood glucose.
That would really be an enormous benefit. For example, these two
scenarios, one was an eat-in scenario in which one ate a modest
medium-sized meal to see how well the closed-loop system could
look at the various levels of glucose control and how that occurred
over the night setting. The second scenario was an eat-out, so you
go out and replicate more of a larger meal that you would have if
you were to go out dining and how well were you able to maintain
that level of glucose control.
These are both very basic investigations that we are hoping to
do, but then, in addition, the more practical, real-life scenarios, and
moving this research forward from the clinic to the bedside.
Senator SHAHEEN. Thank you. Madam Chairman, my time is up,
but I wonder if you would allow me to just ask Mr. Kline one question.
Senator COLLINS. Sure.
Senator SHAHEEN. Thank you very much, Mr. Kline, for being
here and for being willing to testify on what we need to do. If you
had one comment that you could leave with policymakers after todays hearing, what would it be? What would you like us to take
away from this hearing?
Mr. KLINE. Well, I love the questions that you are posing because
they are asking in simple language to explain what the steps are
because so many things get lost along the way in the byzantine labyrinthine hallways of bureaucracy. I love that you are asking for
a timetable and for really simple explanations of when this will
happen and what needs to happen in order to get the artificial pancreas that will alleviate for these children and for type 1 diabetics
around the world the constant burden of self-monitoring, something
that will effectively work as a pancreas works and doles out the appropriate amounts of insulin and glucagon and takes the worry out
of the constant vigilance that type 1 diabetics have to practice.
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Senator SHAHEEN. Thank you. Thank you all very much.
Mr. KLINE. Thank you.
Senator COLLINS. Thank you. Senator Pryor.
Senator PRYOR. Thank you, Madam Chairman.
I would like to start with you, Dr. Zimliki. You have given us
great news on the artificial pancreas. You have said some really
positive, encouraging things about it, but another question that I
do not think I have heard yet is will it be affordable for the average
household? Tell us what you anticipate. What is your expectation
on cost?
Dr. ZIMLIKI. I wish I could give you that answer. The FDA does
not focus on cost. We work on getting the product approved. I will
say that we are collaborating with the Centers for Medicare and
Medicaid Services (CMS) for reimbursement, and the hope is that
one day, not only will the study design I mentioned earlier provide
approval for marketing within the United States, but also for CMS
reimbursement.
Senator PRYOR. You mentioned that there are several models
that may be headed to the marketplace?
Dr. ZIMLIKI. Several types of artificial pancreas systems? Yes.
Senator PRYOR. Do you anticipate that they will all be approximately the same cost, or will there be a big cost disparity?
Dr. ZIMLIKI. Again, I would have to defer to industry, which sets
these prices. I apologize, but I cannot provide an answer to that
question.
Senator PRYOR. So as part of your process, though, you do not
really look at the cost?
Dr. ZIMLIKI. The FDA looks at the safety and effectiveness of the
device.
Senator PRYOR. Well, we will have to work through the cost,
maybe in another setting, but thank you for that answer.
Dr. Rodgers, let me ask you, if I may, how does the United
States compare to other countries when it comes to diabetes research and treatment? Are we leading the world? Are we behind?
How do we rank?
Dr. RODGERS. I think the research that is conducted in the
United States really does lead the world. I think we can be proud
of, in particular, NIH-sponsored research, as well as research that
is sponsored by public groups. In diabetes, in particular, we are
making great strides in understanding the genetic susceptibility.
As I mentioned, in type 1 diabetes, just a few years ago, we had
three genes, now it is up to 50, and we know that among these 50,
for example, there is a small number of genes that contribute a
large amount of the genetic risk, and there is a large number of
genes that have only a small component.
In this country, for the first time, and as a direct result of the
Special Statutory Funding, we are beginning to see now that the
incidence rate of this disease is increasing at an earlier age. We
have to assume that over this period of time, it really is not the
genes that are changing, but it is actually something in the environment. That is why it is critically important to undertake bold
studies to determine what these factors are in the environment
that are contributing to accentuating or initiating that autoimmune
attack.
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And this is why this TEDDY study that I reference in my comments really is going to provide us with a lot of information. Early
on, we are using new technologies, for example, the human micro
biome, in which we are looking at these samples that we are collecting from these children over time, and it is already giving us
information about potential viruses, bacteria, or other agents that
they are exposed to.
Although we are not focusing on type 2 diabetes, the story is
quite similar. Just a few years ago, we just had a few number of
genes. Now we are up to 60 or 70 genes that explain type 2 diabetes. We are seeing that understanding a lot more about type 1 diabetes is really contributing to prevention, potentially treatment, of
type 2 diabetes, as well, which contributes to that $174 billion annual cost that Senator Collins referenced in her opening statement.
Senator PRYOR. So as we do research in the United States, we
are sharing that with the world and others are benefiting from that
research, as well?
Dr. RODGERS. Yes. Certainly, our investigators work that is performed and funded through the NIH is made publicly available so
that others can potentially mine the data and ask other promising
questions. This is how one can really leverage the investments to
get the greatest return on ones investment.
Senator PRYOR. And have we not designated a certain amount of
funding or a percentage of funding to NIH specifically for diabetes
research?
Dr. RODGERS. Well, obviously, the Special Statutory Funding is
exclusively for that
Senator PRYOR. Right.
Dr. RODGERS [continuing]. But over and above that, regularly appropriated funds also go to diabetes research.
Senator PRYOR. And you can see the results of that statutory
funding?
Dr. RODGERS. Oh, absolutely. I just listed a few highlights to give
you a glimpse of that. But over the period of time in which this
funding has occurred, we have really advanced by leaps and
bounds in understanding all steps of the progression of the disease.
Senator PRYOR. My impression is that the number of cases of diabetes has gone up in this country. Are you seeing that all around
the world?
Dr. RODGERS. Of the number of cases of type 1 diabetes that
have been followed, largely, the highest prevalence is in the Scandinavian countries. Finland, for example, has the highest incidence
rate of the disease. The lowest incidence rate, by comparison, is in
Venezuela. And so this clearly may be related to racial, ethnic differences, perhaps exposure in the environment to factors in diet,
maybe sunlight exposure or other things.
But for the first time and as a direct result of the Special Statutory Funding, we have developed a program in collaboration with
the CDC to begin to search for the incidence rate in certain sites
around the country to determine whether our incidence rate is static or whether it is increasing, and we are beginning to see the same
thing that is occurring over in the Scandinavian countries, that not
only over time is the incidence rate increasing, but it is occurring
at a much earlier age.
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Senator PRYOR. And one last thing, if I may, Madam Chairman.
We are seeing that same disparity geographically in this country.
In Arkansas, we have a few counties where the incidence rate is
over 10 percent, and that is not true in other counties. Is it more
concentrated in the Southeastern part of the United States, is that
fair to say?
Dr. RODGERS. I am unaware of any particular predilection for
type 1 diabetes within the United States, but what I would say is
that the Search for Diabetes in Youth Study (SEARCH), in conjunction with the CDC, is allowing us to begin to look at particular
clusters where they may exist. When one sees the clustering of
events, that has a high possibility, or at least opens the possibility,
that there might be local environmental factors, and that is something that we are now poised to be able to look at as the CDC does
for other types of clusters of disease.
Senator PRYOR. Thank you. Thank you, Madam Chairman.
Senator COLLINS. Thank you very much, Senator Pryor. Senator
Begich, welcome.
OPENING STATEMENT OF SENATOR BEGICH
Senator BEGICH. Thank you very much, Madam Chairman. I

know you have an important bill on the floor, so being here today
is a great statement to the group that is here, so thank you for
being here. I know Senator Lieberman also is on the floor. You are
playing tag team, so thank you very much.
I want to make a statement, then I want to ask a couple questions, probably, if I could, to Dr. Zimliki.
First, I am pleased to be here and pleased to get the update on
the current research and hear from so many folks and also from
these young people. I have to tell you, you have been very patient
for the entire presentation and discussion. We could take a lot of
lessons from the young people who sit here so calm and collected,
so thank you very much.
As Mr. Pryor just whispered, if only the Senate could do this,
and I agree with him. [Laughter.]
We have come truly a long way in managing type 1 diabetes on
a day-to-day basis. As a matter of fact, yesterday, I spent some
time with two Alaskans, part of the Childrens Congress, Hugo and
Gus, who I think are right over there. We actually watched the Nationals and the Marinerswe are Seattle fans. We thought we
were winning until the bottom of the ninth, and if anyone watched
that game, it was a pretty exciting game. If you are going to go see
a baseball game, that is the one that was well worth it. So we had
a great chance to talk. They are nodding their heads yes.
But we also had a chance to talk briefly, and we will talk again
later today, but I know their attendance, and the attendance of
their parents, Karen and Steve, and all the families and children
who are here will help us understand better.
But it is exciting, and particularly exciting to see the development of the artificial pancreas that can truly transform lives, and
I understand that we must continue to invest in the tools that help
better manage the disease. I also know that we all really want and
need to invest in research to help find a cure. To this end, we must
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continue to forge the public-private partnerships and leverage
funding to find a cure.
Diabetes is common and growing in the State that I represent,
Alaska. In 2009, nearly 7 percent of Alaskas population had been
diagnosed with diabetes. In 2007, the direct and indirect cost to our
State was approximately $419 million. We can talk about the cost
to the system, but when you look at the other impact, the human
impact to families, the burden of the disease and what families
have to do, it is significant.
This is why I am very glad to have so many people here today
to deliver the impactful and memorable messages. I will tell you,
2 years ago, when I first got here, an Alaskan teenager came and
visited me to advocate on behalf of the Special Diabetes Program,
and she brought me a photo book of her life and what she has been
doing to deal with type 1 diabetes, and it was very amazing because you can talk about it, but when you see the photos of her life
unfold from day one and as she went through it, it was pretty
impactful to me. It is a document and a booklet that I still keep
in my office to remind me of the impact and the stories that are
all around this issue.
Again, I want to thank the parents and the children who are
here. Thank you for your advocacy.
To Dr. Zimliki, if I can ask a couple of quick questions. One, I
want to follow up on your response to Senator Pryor, and that is
you had mentioned the CMS reimbursement.
Dr. ZIMLIKI. Yes.
Senator BEGICH. You said you were working through that, and
no disrespect, but when I have Federal folks in front of me, it is
always, soon, maybe, we are working on it, and I am going to
ask you very specifically. You are working on it. What do you think
the time table is for CMS to actually respond and resolve the issue
of how it is going to be paid for?
Dr. ZIMLIKI. I cannot speak on behalf of CMS, but I can tell you
that the first priority is to develop the appropriate clinical studies
necessary for product approval and marketing within the United
States. We have contacted our CMS affiliates, and we would like
to make sure that the clinical study proposed can not only have the
clinical data necessary for product approval, but also for reimbursement. We are hopeful that we can work with CMS to accomplish
that.
We have also communicated with
Senator BEGICH. Let me pause you there for a second.
Dr. ZIMLIKI. Yes.
Senator BEGICH. When do you think you will have that, because
that is obviously in your control. You are having that discussion.
So when do you think that will get some results so you can say,
we have some partners. We are ready to roll.
Dr. ZIMLIKI. We need to finalize the draft guidance first, and
then
Senator BEGICH. So from December to when, then?
Dr. ZIMLIKI. Developing and publishing this guidance is not a
trivial task.
Senator BEGICH. I understand.
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Dr. ZIMLIKI. This is a huge, monumental effort that the agency
is putting forward. I would like to say that we would have that information available at the same time of the publication of guidance,
but I simply cannot guarantee that date. I apologize for that.
Senator BEGICH. No problem. Based on your experience for something of this magnitude, is it for CMS to say, yes, we can do this;
it will be 2 or 3 years?
Dr. ZIMLIKI. I do not have the experience or the luxury of knowing how long that will take. I will talk to my Commissioner
Senator BEGICH. Perfect. You went right to my next question
Dr. ZIMLIKI [continuing]. And provide you with an answer.
Senator BEGICH. Great. And then maybe you could give me, from
whomever would be the appropriate person at the FDA, experiences of the past and how long it took.
Dr. ZIMLIKI. Absolutely.
Senator BEGICH. I would think that would be important. I would
appreciate that for the record.
The last thing, I will just ask very quickly, and then I apologize,
I have to depart. How many clinical locations do you anticipate for
the trials? Do you have a sense on that yet?
Dr. ZIMLIKI. No. It really depends on how quickly industry wants
to do it and how much variability they want to introduce in their
clinical study design. Certainly, it is more than one location, but
it really is dependent. We have introduced enough flexibility to
allow industry to dictate how many sites they would like to study
and where they would like to study it.
Senator BEGICH. Great. Thank you very much, and I appreciate
the comments, and I look forward to what you can put into the
record. Thank you, Madam Chairman.
Senator COLLINS. Thank you very much.
I want to thank this panel of witnesses for excellent and highly
encouraging testimony this morning. We will continue to work
closely with all of you. Thank you.
[Applause.]
Senator COLLINS. Our next panel of witnesses consists of children who know firsthand the burdens of living with diabetes. Our
witnesses are Caroline Jacobs from Maine; Jack Schmittlein from
Connecticut; Kerry Morgan from Virginia; and Jonathan Platt from
California. All of these children are JDRF Childrens Congress delegates, and we are very happy to have them here today.
Caroline, since you are from my home State, you get to go first.
[Laughter.]
TESTIMONY OF CAROLINE JACOBS,1 DELEGATE FROM
SHAPLEIGH, MAINE, JDRF CHILDRENS CONGRESS
Ms. JACOBS. Good afternoon, Chairman Collins and Members of

the Committee. Thank you for asking me to testify before you
today.
My name is Caroline Jacobs. I am 14 years old. I am from the
great State of Maine, where we say Maine is the way life should
be. I am here as a Childrens Congress delegate to talk about living
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with diabetes, the importance of technology for me and other children with diabetes, and my hope for a cure.
I was diagnosed with diabetes when I was 10 years old. It
changed my life forever. With this disease, I must always think
and be aware of how I am feeling, and I have had to grow up fast.
I feel the burden on my friends and my family who are always worrying about me, always asking me questions about my blood sugar.
So I am doing what I can to make a difference in finding a cure
for juvenile diabetes.
I brought a School Walk for a Cure to my school, and this year
is the third year for my familys walk team for the Walk for a Cure
in Portland. I also make jewelry and bags to benefit JDRF. I do all
of these things so we can continue research to find a cure for diabetes.
While we wait for a cure, I hope to see that more technologies
are made available for children like me. One of the delegates here
is from Canada and has a kind of insulin pump and continuous
glucose monitoring system that protects against episodes of hypoglycemia when the patient is ignoring the dropping sugar levels.
With this ability to stop insulin delivery when it detects a low
blood sugar, this pump could lighten the burden and the worry for
me and those around me. This technology is approved in Canada
and other countries, but not here in the United States. It is hard
for me to understand how a device like that can be available in a
place just over the border from me.
Because I will be driving in the next 2 years, it would be important for me to have access to a technology that could help prevent
my blood sugar from dropping. Having diabetes can make your
blood glucose levels go too high or too low and make me feel sleepy
or dizzy, confused, or have blurred vision, making it too dangerous
to drive.
I would like Congress to encourage the FDA to move forward on
next steps relating to the artificial pancreas, a combination of a
continuous glucose monitor and an insulin pump with software
that communicates between the two. The device will prevent highs
and lows, especially at night when lows can be most dangerous.
But it also would keep control of my sugars while I am driving, as
well.
I hope we will not have to wait too long for this device. That way,
I will no longer have to worry about others always worrying about
me. More importantly, my family will feel less of the burden and
my friends will not always have to adjust around me because of
this disease, and I hope that this means I will have the opportunity
to travel freely without worrying about this disease and enjoy the
world and those who live on it. After all, is that not the way life
should be?
Thank you, Members of the Committee, especially my home
State Senator, Senator Collins.
[Applause.]
Senator COLLINS. Thank you. That was terrific. You sound like
a pro.
Mr. Schmittlein, we are glad to hear from you next.
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TESTIMONY OF JACK SCHMITTLEIN,1 DELEGATE FROM AVON,
CONNECTICUT, JDRF CHILDRENS CONGRESS
Mr. SCHMITTLEIN. Thank you, Senator Collins, Senator Lieberman, and Members of the Committee for inviting me to testify. My
name is Jack Schmittlein. I am 13 years old, and I have had juvenile diabetes for over 6 years.
On October 4, 2004, my life changed forever with my diagnosis.
Instead of being a carefree kindergartner, I was faced with pricking
my fingers 8 to 10 times a day, counting carbohydrates, and taking
insulin shots. Managing diabetes is hard work that lasts 24 hours
a day, every day.
Two years ago, my best friend, Peter, was diagnosed with type
1 diabetes. Before, he had been incredibly helpful in managing my
disease, even keeping me company when I walked to the nurses office to check my blood sugar. Peter and his family learned everything they could about diabetes so that I could come over to play
at their house safely. Peters diagnosis is just one more reason why
I work to raise awareness about type 1 diabetes and one more reason why I am here today.
Important research to find a cure is happening all over the Nation, even at Yale University in my home State of Connecticut, to
better understand the causes of type 1 diabetes and ways to prevent it.
I am grateful that Congress passed legislation to renew the Special Diabetes Program last year. This program is essential to helping find a cure for type 1 diabetes. The Special Diabetes Program
has allowed for research that has led to the artificial pancreas. An
artificial pancreas would help prevent my blood sugar from dropping and give me insulin if my blood sugar gets too high. Right
now, I have to get up to check my blood sugar in the middle of the
night, every night. It would make participating in activities I love
a whole lot easier. I really enjoy playing basketball and football,
but I often have to come out in the middle of a game to test my
blood sugar. It would give me my life back so I can just feel like
a kid again, not a kid with diabetes.
Despite this incredible technology, we need to do everything we
can to find a cure. I am doing my part to help continue to push
life-saving research forward. I have been a JDRF walk team captain for 4 years. I have organized a walk at my school to benefit
JDRF. And I have also spoken about life with diabetes at two
walks, a school assembly, and a Promise Ball fundraiser as a JDRF
Youth Ambassador.
It is my hope that Congress will continue to support research at
NIH, specifically the Special Diabetes Program. I really believe
that we will find a cure for type 1 diabetes. The artificial pancreas
is a promising result after strong investment in research.
I look forward to the day that I can say, I used to have diabetes. Until that day, an artificial pancreas will greatly improve my
daily life and the lives of other children who have type 1 diabetes.
I know that Congress and JDRF are doing all that they can to
make this possible for children like me. Just think, if we can improve the lives of millions of children and adults around the world,
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why would we not? Research being conducted all over the country
is bringing us closer to a cure, and the development of the artificial
pancreas could keep us healthy while we wait for a cure.
Thank you, Senator Collins and Members of the Committee, for
providing me the opportunity to give you a glimpse into what my
life is like with diabetes. I look forward to answering any questions
you may have.
[Applause.]
Senator COLLINS. Thank you, Mr. Schmittlein. You did a great
job.
Ms. Morgan, we will hear from you next.
TESTIMONY OF KERRY MORGAN,1 DELEGATE FROM GLEN
ALLEN, VIRGINIA, JDRF CHILDRENS CONGRESS
Ms. MORGAN. Good afternoon, Senator Collins, Senator Lieberman, and Members of the Committee. Thank you for inviting me
to testify today.
I am Kerry Morgan from Glen Allen, Virginia, and I was diagnosed with diabetes 13 years ago, when I was 4 years old. Unfortunately, diabetes was not new to me when I was diagnosed. My
older sister was diagnosed with the disease when she was four, too.
Shortly after her diagnosis, I was enrolled in a clinical trial for
first-degree relatives of people with type 1 diabetes to determine if
they were at risk for developing the disease. On the trial, I received
daily insulin injections in hopes to avoid or delay development of
diabetes, but it did not work. Sometimes clinical trials do not. I
was formally diagnosed with type 1 diabetes 1 year later.
Then, in what seemed like a flash, 10 years passed10 years
filled with thousands of insulin injections, finger sticks, tubing
changes, endless carbohydrate counting, and worry. Ten years of
toting around an awful green fannypack containing the vital necessities for everyday life. Even with my best efforts, I still have days
with severe high and low blood sugars. My family and I hoped, just
like the millions of people impacted by this disease do, for a better
way to control this.
I was 14 when I enrolled in a clinical trial that was testing a continuous glucose monitoring system. This ingenious device, which I
named my little buddy, gave me instant knowledge of what my
blood sugar was doing and where it was going. While on this trial,
my A1c dropped from an 8 to a 7. This technology made living with
the disease not only easier, but gave me hope that it was truly possible to manage diabetes better. It was not a cure, but it was more
than I had before.
Living with diabetes is a daily struggle. It creates this cloud of
fear and doubt. Thoughts of blood sugars and carbohydrates are always on my mind. I am constantly asking myself, am I OK? I always have to remember snacks and extra supplies to ensure that,
in case of incident, I am covered because things can get scary
quickly. I have had my pump stop working while out of town,
unprompted by dropping it or submerging it in water. I do not just
worry about now. I worry about my future. Diabetes never takes
a break, so neither can I or my family.
1 The
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14:22 Mar 26, 2012
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Then last October, I enrolled in a clinical trial testing artificial
pancreas technology. For 2 days, I was admitted into a hospital
where they tested the closed-loop artificial pancreas system. After
participating in clinical research since I was 3 years old, I can honestly say the closed-loop artificial pancreas trial was the most
amazing experience of my life and holds so much promise for people living with this disease.
For 2 days, I had perfect control of my blood sugar levels. Two
days of living with this technology provided me with the vision of
what life could be likelife with far less complications, both shortand long-term. Creation of an artificial pancreas is within reach. I
know it. I have been a part of it, and I will do all I can to get it
into the hands of people living with diabetes, and I hope you will,
too, so on the day the artificial pancreas is finally approved and released, people with this disease can say, Diabetes? There is an app
for that.
[Laughter and applause.]
Ms. MORGAN. Thank you, Members of the Committee, for all you
do for those living with diabetes and working to make the artificial
pancreas technology available to all those living with this disease.
Senator COLLINS. Thank you very much, Ms. Morgan, for great
testimony.
[Applause.]
Senator COLLINS. Mr. Platt, you are up next.
TESTIMONY OF JONATHAN PLATT,1 DELEGATE FROM
TARZANA, CALIFORNIA, JDRF CHILDRENS CONGRESS
Mr. PLATT. Good afternoon, Chairman Collins and other Members of the Committee. Thank you for inviting me to testify.
My name is Jonathan Platt. I am from Tarzana, California, a
suburb of Los Angeles. I am 7 years old. I was diagnosed with juvenile diabetes at age 6. I had been losing weight, wetting the bed
at night, and had extreme thirst. I was always very tired and emotional. My mom and dad thought I was adjusting to a new school
and kindergarten. My blood sugar was over 650 when I was diagnosed with juvenile diabetes. I will never forget the day I was diagnosed. We found out later that the little red-headed girl who rode
in the elevator with us was diagnosed with juvenile diabetes, also.
That had never happened before in this doctors office, two children
diagnosed at the same time. I was thinking, how did I get this disease? I did not know what it was. I was very scared and nervous.
I am here as a Childrens Congress delegate to tell you that I
manage my disease, but I do not let it control my life. With this
disease, I am able to swim, play basketball, and build Legos, but
I am different. Unlike other children, I have to check my blood
sugar 8 to 10 times a day. Everything I eat is measured and every
carbohydrate counted. My blood sugar kit, juice, glucagon, and ketone strips go with me everywhere I go.
It is hard when I go to summer camp or do a sleepover or even
go to a friends house. Too much exercise or not eating all my food
can be very dangerous. I think I am too young to have to worry
about all this stuff.
1 The
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My parents have had to adjust their life because of my diabetes,
but they say we all have it, not just me. Managing diabetes is a
24-hour job. We are doing our part to help find a cure by raising
money for the JDRF Walk for a Cure. I am here to ask you to continue to do your part and fund research to find a cure.
A cure for diabetes means that I could go to any summer camp
and have sleepovers whenever and wherever I want. It means I
could be a regular kid again, and most of all, it would mean I
would not have diabetes. Please help me make this possible. My
life depends on it. Thank you.
Senator COLLINS. You did a great job.
[Applause.]
Senator COLLINS. I think this entire panel deserves another
round of applause.
[Applause.]
Senator COLLINS. Now, I know that the children here have been
sitting a very long time and that many of them could use a snack
or water or need to test themselves, so I am going to ask the panel
to each just ask one question, and then we will just wrap up the
hearing because I know it has been a long afternoon, particularly
for some of the younger delegates who are here.
First of all, thank you all for just wonderful testimony. You really have put a human face on what it is like to have diabetes, and
that is far more powerful than statistics. You are the best advocates for funding for diabetes research that we could possibly have.
So, Caroline, my question is going to be for you. You were diagnosed in the summer, and you had some time with your family to
get used to the idea of having diabetes and to learn what you needed to do in order to manage your disease. But I would like you to
share with us what it was like when you went back to school in
the fall.
Ms. JACOBS. Well, I was going to a new school at the time, so
I was teaching my teachers how to deal with having a kid with diabetes and teaching my new friends how to count carbohydrates and
all that stuff. Even at lunch, we would all try to figure out how
many carbohydrates were in my food. I had a lot of support from
friends, teachers, and my family, of course.
Senator COLLINS. I am sure that made a real difference.
Ms. JACOBS. Yes.
Senator COLLINS. Senator Begich referred to the scrapbook, and
you gave me yours, and it is wonderful to go through it because I
have learned so much more about the disease and about you. I
want to thank you especially for being here, but I also want to
thank all of our delegates.
Ms. JACOBS. Thank you very much.
Senator COLLINS. Senator Brown.
Senator BROWN. Thanks, Madam Chairman, again, for holding
this hearing. Looking out there, I think I am at the Academy
Awards. I see Mr. Kline right there, and then I come back to reality, and I see that we are here to discuss something very serious.
Obviously, it affects everybody in this room. The wonderful part
about being a U.S. Senator is, each day, you can learn and grow
and you can understand new and different things, and if you do not
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understand them, you obviously have an opportunity to actually
find out the answers, which I find intellectually very stimulating.
Jonathan, I agree with you. You are too little to have to worry
about this stuff. That being said, what has been the biggest challenge for you since you recently found out? What is the most difficult part of everything that you are going through right now?
Mr. PLATT. Well.
Senator BROWN. Is it keeping the daily requirements? Is it worrying about what happens if you do not do it right? I mean, what
is the biggest challenge, do you think?
Well, you think about it for a minute. I am going to ask Mr.
Schmittlein. What is your biggest challenge?
Mr. SCHMITTLEIN. Probably my biggest challenge with diabetes is
at school, when all of my friends go to lunch, I have to always go
to the nurse, and I have to bolus through my lunch, and sometimes, if we are in class and doing something fun, my blood sugar
might be too low or too high, and so I will have to go down to the
nurse and miss out on all the fun. So that is kind of hard for me
because it is not fun to miss out on things you really want to do
with your friends, so that is one of the things that is challenging
for me.
Senator BROWN. Jonathan, you said earlier that your blood sugar
was over 650, and I learned something today, that the average is
100 or below. I find that amazing that you were able to really function and now, obviously, address it. Have you thought of something
that is challenging yet for you?
Mr. PLATT. Yes. Every time I feel low, there is no nurse at the
school, and while in the library when there is something fun, if I
feel low, I will have to go back to the class and check my blood
sugar with the teachers.
Senator BROWN. So you are missing out on some things.
Mr. PLATT. Yes.
Senator BROWN. Well, thank you for that.
Thank you, Madam Chairman, for holding this hearing, and
thank you, panelists.
Senator COLLINS. Thank you very much, Senator Brown.
Senator Shaheen.
Senator SHAHEEN. Thank you. Thank you all very much for your
testimony. You are great advocates for the need to do more to address research.
Ms. Morgan, since you have not answered a question, my question is for you. We still have Dr. Zimliki and Dr. Rodgers here, and
there has been a lot of discussion today about the artificial pancreas. Since you participated in one of those trials, is there anything that you would like to tell them about that trial that you
hope they will bear in mind as they go back to the NIH and the
FDA and continue work on trying to get an artificial pancreas that
can be available to people?
Ms. MORGAN. The first thing I am going to say is it is awesome,
so keep that in mind. And being on the artificial pancreas was so
different than just living every day with diabetes because for that
time, I did not have to worry. I did not have to think about it, and
that was a new experience for me because I have had this disease
since I was so young, I do not really know anything else. And so
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not having to do that was such a weight off of my shoulders, and
I think everyone here could use that. And so bear in mind that I
think we need it and we need it soon, so keep working, keep funding, keep researching, and hopefully, it will be out soon.
Senator SHAHEEN. Thank you very much.
[Applause.]
Senator SHAHEEN. And thank you, Madam Chairman, for holding
the hearing and for all of your work chairing the Diabetes Caucus.
As we can see, it really is making a difference.
Senator COLLINS. Ms. Morgan, I really think that your final
words sum up why we are here and what our purpose is. But I do
want to take this opportunity to thank everyone for coming to this
hearing, the wonderful witnesses that we had, the delegates who
were chosen to testify, all of the delegates who are sitting in the
well and around the room, and their families because diabetes
truly is a disease that affects the entire family.
I want to thank the Juvenile Diabetes Research Foundation for
working so closely with us. Mary Tyler Moore sent a letter and
some testimony that we are going to put into the record, and we
will have the record open for an additional 15 days in case anyone
else has any words of wisdom for us or additional questions.1
But most of all, I want to thank the children who are here today.
When you come to Washington and you meet with your Senators
and Members of Congress, you make such a difference. It is because you are willing to come here and tell your personal stories
that we have been successful in tripling the funding for research
that goes for diabetes. And I know that with your help, we will one
day soon have better treatmentsthe artificial pancreas that we
have talked about todaybut also, ultimately, the goal of all of us
here, and that is a cure.
So I thank you all for coming to Washington, for being here with
us, and for being such great advocates.
This hearing is now adjourned.
[Whereupon, at 3:32 p.m., the Committee was adjourned.]
1 The
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Transforming Lives Through Diabetes Research

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Transforming Lives Through Diabetes Research

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TRANSFORMING LIVES THROUGH DIABETES

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For sale by the Superintendent of Documents, U.S. Government Printing Office

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COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

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TRANSFORMING LIVES THROUGH DIABETES

Chairman LIEBERMAN. Good morning. The hearing will come to

Senator COLLINS [presiding]. Thank you. Thank you so much,

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Senator AKAKA. Thank you very much, Senator Collins. I deem

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Senator BROWN. Thank you, Madam Chairman and Senator

Senator SHAHEEN. Thank you, Madam Chairman, and thank you

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prepared statement of Senator Shaheen appears in the Appendix on page 40.

Senator LAUTENBERG. I have a granddaughter, also, that I am

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Mr. KLINE. Senator Collins, thank you. Senator Lieberman,

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prepared statement of Mr. Kline appears in the Appendix on page 42.

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prepared statement of Dr. Rodgers appears in the Appendix on page 44.

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charts referenced by Dr. Rodgers appear in the Appendix on page 61.

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Dr. ZIMLIKI. Well, I share that excitement, as well. Madam

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prepared statement of Dr. Zimliki appears in the Appendix on page 64.

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